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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Detector And Alarm, Arrhythmia
510(k) Number K140548
Device Name CORCAM HEART MONITOR
Applicant
CORCAM TECHNOLOGIA, SA
575 EIGHTH AVE, STE 1212
NEW YORK,  NY  10018
Applicant Contact JENNIFER A DAUDELIN
Correspondent
CORCAM TECHNOLOGIA, SA
575 EIGHTH AVE, STE 1212
NEW YORK,  NY  10018
Correspondent Contact JENNIFER A DAUDELIN
Regulation Number870.1025
Classification Product Code
DSI  
Date Received03/04/2014
Decision Date 05/23/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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